Drug application

TOFACITINIB CITRATE (TOFACITINIB CITRATE)

Drugs@FDA ANDA 209813 · TEVA PHARMS USA

Key facts

Drug name TOFACITINIB CITRATE
Active ingredients TOFACITINIB CITRATE
Application type ANDA
Application number 209813
Company TEVA PHARMS USA
Dosage forms TABLET, EXTENDED RELEASE, ORAL
Strength EQ 11MG BASE
Marketing status Prescription
TE codes AB
Reference listed drug No
Latest submission status date Aug 17, 2026

At a glance

  • 1–9 Submissions
  • None Label versions
  • 1–9 Products
  • 10–99 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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